FDA: The heart-checking smart toilet seat is a go

After years in development, the FDA has said a smart, sensor-laden toilet seat has passed the agency’s muster.

Casana—a startup describing itself as “the industry leader in monitoring heart health through smart toilets”—has received a green light for its Heart Seat to log users’ pulse rate and blood oxygen saturation, as part of its pitch for “effortless” at-home patient monitoring.

The company, formed as a spinout of the Rochester Institute of Technology, said it also plans to seek additional FDA clearances for checking blood pressure every day (or more), and aims to have its Heart Seat publicly available by the end of this year.

“As medicine moves from the physician’s office into the home, accurate home monitoring of medical parameters is increasingly important,” George Bakris, a Casana advisor and director of UChicago’s Comprehensive Hypertension Center, said in a release.

Meeting patients and customers where they are—and on their terms—is serious business: Casana estimates the entire home healthcare market at well over $300 billion and growing fast. Meanwhile, cardiovascular disease remains the leading cause of death worldwide, with nearly half of adults in the U.S. living with high blood pressure.

The battery-powered, Internet-connected Heart Seat is designed to replace a standard home toilet seat, automatically capturing and uploading SpO2 and heart rate data using the same types of sensors built into smartwatches and other devices for checking vital signs. 

The system can also flag readings for healthcare providers The FDA cleared its use in adults ages 22 and older.

Early last year Casana raised $30 million to help carry its device through regulatory review, as well as complete clinical studies conducted through the Smart Integrated Technologies Lab, or SIT Lab, located at its Rochester, N.Y. headquarters. Its series B round was joined by Morningside, Matrix Partners, General Catalyst and Outsiders Fund.

The toilet of the future may come to house more than one medical device. Withings earlier this year debuted a bowl-mounted digital lab to capture urine-related biomarkers, offering a glimpse into hydration and nutrient levels as well as ovulation and cycle tracking.

After four years in development, the rechargeable, puck-shaped U-Scan contains a rotating cartridge-based system capable of running dozens of tests and is cleaned with each flush. It aims to record information on a regular basis that would otherwise only be examined by professionals once a year.